A Study Evaluating Tolerability and Efficacy of Navitoclax in Combination With Ruxolitinib in Subjects With Myelofibrosis
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/13/2019 |
Start Date: | October 31, 2017 |
End Date: | May 14, 2021 |
Contact: | ABBVIE CALL CENTER |
Email: | abbvieclinicaltrials@abbvie.com |
Phone: | 847.283.8955 |
A Phase 2 Single-Arm, Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax in Combination With Ruxolitinib in Subjects With Myelofibrosis
This is a Phase 2, single-arm, open-label, multicenter study evaluating efficacy, safety and
tolerability of navitoclax added to ruxolitinib in participants with myelofibrosis.
tolerability of navitoclax added to ruxolitinib in participants with myelofibrosis.
Inclusion Criteria:
- Participants with documented diagnosis of primary Myelofibrosis, post polycythemia
Vera Myelofibrosis or post-essential thrombocythemia myelofibrosis
- Participant must be ineligible or unwilling to undergo stem cell transplantation at
time of study entry
- Participant must have received ruxolitinib therapy for at least 12 weeks and be
currently on a stable dose of >= 10 mg BID of ruxolitinib for >= 8 weeks prior to the
1st dose of navitoclax, ECOG of 0,1, or 2.
Exclusion Criteria:
- Splenic irradiation within 6 months prior to screening, or prior splenectomy.
- Leukemic transformation (> 10% blasts in peripheral blood or bone marrow biopsy).
- Participant is currently on medications that interfere with coagulation (including
warfarin) or platelet function with the exception of low dose aspirin (up to 100 mg)
and Low-molecular-weight heparin.
We found this trial at
14
sites
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